AGREE: Aspirin Combined With Clopidogrel Versus Intravenous Alteplase for Acute Minor Stroke
Study Details
Study Description
Brief Summary
An open-label, blinded endpoint, randomized controlled trial that includes patients diagnosed with non-disabling, non-large vessel occlusion, acute minor stroke within 4.5 hours of onset. Eligible participants would be randomly assigned to the thrombolysis group (intravenous alteplase) and the dual antiplatelet group (oral aspirin plus clopidogrel). The primary outcome is the proportion of the excellent functional outcome (modified Rankin scale 0-1) at 90 days.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: DAPT group Receiving dual antiplatelet therapy immediately after randomization (Oral aspirin 100mg+clopidogrel 300mg, Day 1). Participants who show no evidence of intracranial hemorrhage on skull CT 24 hours after randomization will receive oral aspirin 100mg/d (Day 2-90) and clopidogrel 75mg/d (Day 2-21), while those with intracranial hemorrhage on skull CT will not receive any antiplatelet drugs. |
Drug: Aspirin
See arm/group descriptions.
Drug: Clopidogrel
See arm/group descriptions.
|
| Active Comparator: IVT group Receiving intravenous thrombolysis immediately after randomization (Intravenous alteplase, 0.9mg/kg, a maximum dosage of 90mg). Participants who show no evidence of intracranial hemorrhage on skull CT 24 hours after randomization will receive oral aspirin 100mg/d (Day 2-90), while those with intracranial hemorrhage on skull CT will not receive any antiplatelet drugs. |
Drug: Alteplase
See arm/group descriptions.
|
Outcome Measures
Primary Outcome Measures
- The modified Rankin Scale score (mRS) 0-1 [90(±7) days]
The proportion of the modified Rankin Scale score (mRS) 0-1 at 90 days.
Secondary Outcome Measures
- The modified Rankin Scale score (mRS) 0-1 [7(±1) days]
The proportion of the modified Rankin Scale score (mRS) 0-1 at 7 days or discharge (whichever occurred first).
- Early neurological deterioration [7(±1) days]
The incidence of early neurological deterioration at 7 days.
- Recurrent stroke [90(±7) days]
The incidence of recurrent stroke at 90 days.
Other Outcome Measures
- SAFETY OUTCOME: Symptomatic intracranial hemorrhage [24 (±12) hours]
Symptomatic intracranial hemorrhage within 36 hours (according to Heidelberg criteria)
- SAFETY OUTCOME: Mortality [90(±7) days]
Mortality at 90 days
- SAFETY OUTCOME: Any intracranial hemorrhage [24 (±12) hours]
Any intracranial hemorrhage within 36 hours (according to Heidelberg criteria)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 40-80 years.
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Diagnosed with acute ischemic stroke, NIHSS ≤ 5 and single item score ≤ 1 for vision, language, single limb, and no impairment of consciousness.
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Time from symptoms onset to randomization within 4.5 hours; the onset time refers to the "Last Known Normal" (LKN).
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Absence of large vessel occlusion on CTA.
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Pre-stroke mRS ≤ 1.
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Signed informed consent.
Exclusion Criteria:
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Clinically confirmed valvular or non-valvular atrial fibrillation requiring anticoagulation therapy.
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Intracranial hemorrhage or subarachnoid hemorrhage suggested by CT scan.
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Acute coronary syndrome suggested by Electrocardiogram.
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History of gastrointestinal bleeding.
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Planned sequential IVT or endovascular treatment.
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History of allergy to aspirin, clopidogrel, and/or alteplase.
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Systolic blood pressure exceeding 185 mmHg and/or diastolic blood pressure exceeding 110 mmHg despite antihypertensive treatment.
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Blood glucose ≤ 2.7 mmol/L.
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Epileptic seizures during a stroke attack.
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Recent trauma (<15 days).
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Recent intracranial or spinal cord surgery, head trauma, or stroke (<3 months).
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History of intracranial hemorrhage, aneurysm, vascular malformation, or brain tumor.
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Active visceral hemorrhage (<22 days).
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History of anticoagulant use within 24 hours prior to onset.
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Platelets <100,000, PTT > 40 seconds on heparin, or PT > 15 or INR > 1.7, or known bleeding disposition.
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Anticipated life expectancy < 3 months.
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Pregnant or lactating women.
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Participation in other clinical trials.
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Any condition that, in the judgment of the investigator, makes the patient unsuitable for this study or where this study may impose a significant risk to the patient (e.g., inability to understand and/or comply with study procedures and/or follow-up due to psychiatric disorders, cognitive or emotional impairment).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | China | 510120 |
Sponsors and Collaborators
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
- Principal Investigator: Yamei Tang, Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SYSKY-2022-252-02